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Use of Ceftaroline 30μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in Clinical Infections Against:
Gram-positive Microorganisms
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus pneumoniae
Gram-negative Microorganisms
Escherichia coli
Klebsiella pneumoniae
Klebsiella oxytoca
Haemophilus influenzae

Active In Vitro Against:
Gram-positive Microorganisms
Streptococcus dysgalactiae
Gram-negative Microorganisms
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Moraxella catarrhalis
Morganella morganii
Proteus mirabilis
Haemophilus parainfluenzae

Ceftaroline 30ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Ceftaroline supplied by the drug manufacturer. Each Ceftaroline disk is clearly marked on both sides with the agent and drug content. Ceftaroline cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ceftaroline disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Aqar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.

This submission for the Ceftaroline 30µg BBL Sensi-Disc Antimicrobial Susceptibility Test Disks is for an in vitro diagnostic (IVD) device. The provided text outlines the intended use, device description, and comparison to a predicate device, focusing on its function in determining bacterial susceptibility to Ceftaroline. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format typically required for medical device clinical studies in the context of human imaging or diagnostic algorithms.

The document refers to the Ceftaroline drug package insert, "Microbiology" for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This indicates that the performance of the antimicrobial susceptibility test disk is tied to the established performance and microbiology data of the Ceftaroline drug itself, which would have undergone rigorous clinical trials for its efficacy and determination of susceptibility breakpoints. The 510(k) submission is confirming that the method of testing (using the Sensi-Disc) provides results consistent with the drug's known microbiological profile.

Therefore, many of the requested points cannot be directly answered from the provided text, as they pertain to a different type of device evaluation (e.g., studies involving human readers, imaging data, or AI algorithms).

Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance in terms of sensitivity, specificity, accuracy, or other typical metrics for a diagnostic algorithm. Instead, for IVD susceptibility testing, the acceptance criteria are based on comparing zone sizes around the disk to established zone size ranges for individual antimicrobial agents, which are determined by the antimicrobic manufacturer and FDA approved under the drug's NDA (Number 200327). These are also guided by CLSI/NCCLS standards (M2 and M100). The "performance" of the device is its ability to produce inhibition zone diameters that consistently fall within these established ranges for control organisms and accurately categorize clinical isolates as Susceptible (S), Intermediate (I), or Resistant (R) according to the FDA drug insert and CLSI/NCCLS documents.

Specific performance data for this device is explicitly stated to be in the Ceftaroline drug package insert, "Microbiology." Therefore, a table of this data cannot be created from the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. It would be contained within the "Microbiology" section of the Ceftaroline drug package insert. For antimicrobial susceptibility testing, the "test set" would typically consist of a variety of bacterial isolates, including both wild-type and resistant strains, collected from various clinical sources.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For antimicrobial susceptibility testing, "ground truth" is typically established by reference methods like broth microdilution or agar dilution as defined by CLSI. The establishment of these reference values usually involves a consensus process by expert microbiologists and laboratory professionals within organizations like CLSI. It isn't tied to individual experts interpreting results, but rather to standardized laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods like 2+1 are typically used in scenarios where human interpretation of complex data (e.g., medical images) needs consensus. For antimicrobial susceptibility testing, the measurement of inhibition zones is objective, and interpretive categories (S/I/R) are determined by comparing measurements to predefined breakpoints, not by expert consensus on each individual test result.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable and not provided. The device is a physical disk for manual susceptibility testing, not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes related to AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical Sensi-Disc; it is not an algorithm. The "algorithm" for interpretation involves measuring a zone diameter and comparing it to a published table, which inherently involves human observation and measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for antimicrobial susceptibility testing is established by reference methods such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC) of the drug against a particular bacterial isolate. These reference methods are standardized by organizations like CLSI and are based on extensive microbiological data. The zone diameter breakpoints for the Sensi-Disc are then correlated to these reference MIC values.

8. The sample size for the training set

This information is not explicitly provided. For IVD devices like this, the "training set" doesn't refer to an AI training set. Instead, it refers to the collection of bacterial isolates used during the development and validation of the disk diffusion method and the establishment of interpretive zone diameter breakpoints. This data would be found in the microbiological studies supporting drug approval and CLSI guidelines.

9. How the ground truth for the training set was established

Similar to point 7, the "ground truth" for establishing the correlation between zone diameters and MICs (which leads to the S/I/R interpretive categories) is based on standardized reference antimicrobial susceptibility testing methods (e.g., broth microdilution or agar dilution) performed on a large collection of characterized bacterial isolates. These methods provide the MIC values, against which the zone diameters from the disk diffusion method are correlated. This process is outlined in CLSI guidelines and validated during the drug approval process.

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The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a luer connector, The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and luer adapter are color-coded.

The provided text describes the BD Nexiva™ Diffusics™ Closed IV Catheter System, primarily focusing on its substantial equivalence to predicate devices based on bench testing. It does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, or standalone performance. The document explicitly states: "No clinical test results were included in this submission."

Therefore, I cannot fulfill most of your request directly from the provided text. However, I can extract the information that is present concerning the testing done.

Here's a summary of what can be inferred and what is missing:

Summary of Device Performance and Testing (from provided text):

The submission for the BD Nexiva™ Diffusics™ Closed IV Catheter System relies on bench testing to demonstrate performance and substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The text states, "Studies were designed and performed to demonstrate that the BD Nexiva Diffusics device met-predetermined product specifications." However, the specific predetermined product specifications (acceptance criteria) are not detailed in the provided document.
• Reported Device Performance: The document generally states, "Nonclinical test results and technological characteristics of like gauge size catheters were shown to be equivalent between the subject device and the predicate device." And "The BD Nexiva Diffusics (subject) device met the minimum requirements and are substantially equivalent in design, materials, sterilization, principles of operations and indications for use to the predicates."
  • Specific performance metrics or numerical outcomes from the bench tests are not provided.
  • The testing performed included:
    • In-vitro testing in accordance with ISO 10555-1 and ISO 10555-5 (which generally cover sterile, single-use intravascular catheters).
    • Flow rate testing.
    • Catheter strength and performance.
    • Clamp performance.
    • Labeling durability.
    • Extension tube and septum integrity.
    • Biocompatibility evaluation in accordance with ISO 10993-1.

2. Sample size used for the test set and the data provenance:

• Sample Size: The sample sizes used for the bench tests are not specified in the provided text.
• Data Provenance: The data provenance (country of origin, retrospective/prospective) for the bench tests is not specified. Given it's bench testing, it would likely be conducted in a laboratory setting, not tied to a country of patient data, and inherently prospective for that specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as there were no clinical studies or human expert evaluations mentioned for establishing ground truth. The submission relies solely on bench testing and comparison to predicate devices, not on human diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This question is not applicable as there were no human evaluations or a "test set" in the context of diagnostic interpretation that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. The document explicitly states: "No clinical test results were included in this submission." The device is a physical medical device (IV catheter), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable as the device is an IV catheter, not an algorithm or AI system.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be established by the predefined product specifications and performance standards (e.g., ISO 10555, ISO 10993) which the device had to meet. These are objective engineering and material science standards, not expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set:

• This question is not applicable as the device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• This question is not applicable as the device is not an AI/ML algorithm.

In summary, the provided document focuses on demonstrating substantial equivalence through bench testing against established industry standards and comparison to predicate devices. It explicitly states that no clinical tests were included, meaning there are no details about human or AI performance, expert involvement, or related statistical measures.

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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.

The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.

The provided text describes the performance testing of the BD 23G X 7mm Pen Needle, focusing on its equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each bench test. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as "bench tests," implying laboratory-based evaluations rather than clinical studies with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. Bench testing for medical devices like pen needles typically relies on objective measurements against international standards (e.g., ISO) and internal design specifications, rather than expert consensus on subjective observations.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are not applicable to the described bench tests. These methods are typically used in clinical trials involving interpretation of medical images or patient outcomes, where human experts might disagree on subjective assessments. The tests for the pen needle are objective, measurable parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes bench tests comparing the new device to predicate devices on physical and mechanical properties, not a study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical instrument (pen needle), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was established by international standards (ISO 11608-2, ISO 7864) and internal BD design verification protocols. These standards define the acceptable physical and mechanical properties of pen needles. For example, the patency of the lumen is verified by the passage of a stylet of a specific diameter, which is a direct, objective measurement against a defined standard, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical pen needle, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no training set for a physical device like a pen needle.

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The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

BD Vacutainer® Tubes are sterile, single-use, evacuated plastic blood collection tubes with rubber stoppers that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turn-around-time is necessary.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims "substantially equivalent performance" to the predicate device, the BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™). This implies that the acceptance criteria for individual analytes were likely defined as meeting pre-determined equivalence bounds (e.g., within a certain percentage difference, or within clinical significance ranges). However, the specific quantitative acceptance criteria for each analyte are not explicitly stated in this document. The reported performance is that the device met these unstated equivalence criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was performed on blood collected in both the evaluation and predicate tubes" but does not give a specific number of samples or subjects.
• Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable here. The study assesses the performance of a blood collection tube for clinical chemistry measurements, not the interpretation of medical images or diagnostic results that would typically require expert ground truth establishment. The ground truth for this type of test is the objective measurement of analytes by laboratory instrumentation.

4. Adjudication Method for the Test Set

This information is not applicable as the study design focuses on objective laboratory measurements rather than expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a study evaluating a blood collection device, not an AI-assisted diagnostic tool involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This information is not applicable. This is a study of a medical device (blood collection tube) with laboratory performance assessments, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be the objective laboratory measurements/values of the various chemistry, serology, and immunology analytes obtained from the blood samples. This is determined by validated laboratory instruments and methodologies, not by expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

This information is not applicable. This study does not involve a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a machine learning algorithm in this study.

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